Relapsed Malignant Solid NeoplasmPhase 1NCT05865002
A Study Evaluating the Safety and Efficacy of AUR107 in Patients With Relapsed Advanced Malignancies (SHAKTI-1)
A Phase 1 study testing AUR107 in people with Relapsed Malignant Solid Neoplasm, run by Aurigene Discovery Technologies Limited at 37 sites in India.
Trial summary
An open-label, first-in-human, Phase 1 study in adult patients with relapsed advanced malignancies will be done to assess AUR107 safety, tolerability, pharmacokinetics, pharmacodynamics, and optimal biological dose. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed Malignant Solid Neoplasm
- What is being tested?
- AUR107
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 37 sitesIndia
- Study dates
- 5 Sep 2023to Jun 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females ≥ 18 years of age.
- Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1.
- Acceptable bone marrow and organ function at screening as described below:
- ANC ≥ 1500/μL (without WBC growth factor support)
- Platelet count ≥ 100,000/μL without transfusion support
- Hemoglobin ≥ 9 g/dL (Transfusion is allowed to achieve this Hb)
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- Total Bilirubin ≤ 1.5 x ULN; (Patients with known Gilbert's syndrome are allowed with a Total Bilirubin ≤ 2.5 x ULN)
- AST (SGOT) ≤ 3 x ULN (≤ 5 × ULN if known liver metastases)
- ALT (SGPT) ≤ 3 x ULN (≤ 5 × ULN if known liver metastases)
- Creatinine clearance (CrCl) ≥ 60 mL/min (either measured or estimated by the Cockcroft-Gault formula).
- Ability to swallow and retain oral medications.
- Histopathological diagnosis of a solid tumor. Note: The solid tumors must be in Stage IV at screening.
- Evidence of measurable disease per RECIST, v1.1 for solid tumors.
- Standard curative measures do not exist, and the patient must have exhausted all effective therapies available locally.
- Notes:
- 7a. At a minimum, solid tumor patients must have received at least two lines of systemic therapies in the metastatic incurable settings (these two lines must be in the metastatic setting and not in the earlier stage of cancer).
- 7b. Any cancer patient with access to any effective therapy must not be enrolled
Who cannot join
- Systemic anti-cancer therapy, such as chemotherapy, biological therapy, or immunomodulatory drug therapy, received within the past 28 days or 5 half-lives, whichever is longer, from Cycle 1 Day 1 of the study.
- Note: Concomitant use of low-dose prednisone (up to 10 mg/day) or medroxyprogesterone is allowed.
- Note: Patients with CRPC (castrate-resistant prostate cancer) should continue to receive ongoing medical castration with LHRH analogs, and such patients are allowed.
- Presence of acute or chronic toxicity resulting from prior anticancer treatment, with the exception of alopecia or nail changes, that has not resolved to Grade ≤ 1, as determined by NCI CTCAE v 5.0.
- Definitive Radiotherapy within the last 21 days of Cycle 1 Day 1 (limited field palliative radiation is allowed and no restrictions during the screening period or during the trial)
- Use of any investigational agent within 28 days or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1.
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- Use of drugs which are moderate / strong CYP3A4 inducers and/or drugs which are predominantly metabolized by CYP3A4 within 1week or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1.
- Note: This class of drugs are also prohibited during DLT evaluation period and must be either avoided or used with caution beyond DLT evaluation period.
- Known symptomatic or untreated or recently treated (≤ 6 months of screening) central nervous system (CNS) metastases. Patients with previously treated (> 6 months of screening) CNS metastases and are now stable and asymptomatic, from CNS perspective, are allowed.
- Major surgery ≤ 28 days from Cycle 1 Day 1 (major surgery is defined as a procedure requiring general anesthesia).
- Patients with leukemia, myelodysplastic syndrome, multiple myeloma, or lymphoma.
- Active infection requiring systemic therapy. Note: Prophylactic use of antibiotics is allowed. Any infection detected during the screening period which is resolved adequately according to investigator before the Cycle 1 Day 1, is allowed.
- Known to be human immunodeficiency virus (HIV) positive or have an acquired immunodeficiency syndrome-related illness.
- Known active or chronic hepatitis B (HBsAg +ve) or hepatitis C infection (HCV antibody +ve).
- The patient who is expected to require any other form of antineoplastic therapy or targeted therapy while on study.
- Uncontrolled congestive heart failure (New York Heart Association [NYHA] Class 2-4), angina, myocardial infarction, cerebrovascular accident, coronary/peripheral artery bypass graft surgery, or transient ischemic attack, or pulmonary embolism within 3 months prior to Cycle 1 Day 1.
- Ongoing cardiac dysrhythmias requiring treatment of any grade or treatment of cardiac dysrhythmias in the past 3 months, before Cycle 1 Day 1.
- QTc (Bazzett) interval >460 ms on ECG at screening and/or at Cycle 1 Day 1 pre-dose.
- Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or significant gastritis, active bleeding diatheses, presence of any major medical illness (e.g., renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, or psychiatric illness/social situations or clinically significant laboratory / ECG abnormalities at screening, any or a combination of illnesses, which, in the opinion of the PI, may either put the patient at risk because of participation in the study or influence the results or the patient's ability to participate in the study.
- Current swab-positive or suspected (under investigation) Covid-19 infection or fever and other signs or symptoms suggestive of Covid-19 infection with recent contact of the person(s) with confirmed Covid-19 infection, at screening or Day 1 of Cycle 1.
- Positive pregnancy test for women of childbearing potential (WOCBP) at the screening or enrolment visit.
- Lactating women or WOCBP who are neither surgically sterilized nor willing to use reliable contraceptive methods. (hormonal contraceptive, IUD, or any double combination of the male or female condom, spermicidal gel, diaphragm, sponge, cervical cap).
Trial locations and contacts
37 sites in 1 country. Contact the study team or a site near you to ask about taking part.
37 sites in 1 country
India37 sites, 35 recruiting
- Recruiting
Apollo Hospital International Limited
Ahmedabad, Gujarat, 382428
Dr Velu Nair, 9818256670, drvelunair@cbccusa.in
Dr Velu Nair
- Active, not recruiting
Sri Shankara Cancer Hospital and Research Centre
Bangalore, Karnataka, 560004
- Recruiting
Healthcare Global Enterprises Ltd
Bangalore, Karnataka, 560027
Dr Nataraj KS, 9482141773, drnataraj.ks@hcgel.com
Dr Nataraj KS
- Recruiting
Cytecare Hospitals Pvt. Ltd
Bangalore, Karnataka, 560064
Dr Harish P, 9871282588, harish.p@cytecare.com
Dr Harish P
- Recruiting
Vydehi Institute of Medical Sciences and Research Centre
Bangalore, Karnataka, 560066
Shashidhar V Karpurmath, MBBS, 8861085629, shashivk5@gmail.com
- Recruiting
KLEs Dr. Prabhakar Kore Hospital & Medical Research Center
Bangalore, Karnataka, 590010
Dr Rohan Bhise, 9448866712, rohanbhise30@gmail.com
Dr Rohan Bhise
- Recruiting
Sparsh Hospital & Critical care(P) LTD
Bhubaneswar, Odisha, 751007
Dr Ghanashyam Biswas, 9937500878, drgbiswas@gmail.com
Dr Ghanashyam Biswas
- Recruiting
Post-Graduate Institute of Medical Education and Research(PGIMER)
Chandigarh, Chandigarh, 160012
Dr Gaurav Prakash, 9914209678, drgp04@gmail.com
Dr Gaurav Prakash
- Recruiting
Krupamayi Hospital
Chhatrapati Sambhajinagar, Maharashtra, 431001
Dr Viraj Vijay Borgaonkar, +91 9673073555, viraj.oncosurg@gmail.com
- Recruiting
Apollo Cancer Hospital
Hyderabad, Telangana, 500033
Dr Padmaja Lokireddy, 9553077700, drloki2002@yahoo.com
Dr Padmaja Lokireddy
- Recruiting
Basavatarakam Indo American Cancer Hospital & Research Institute
Hyderabad, Telangana, 500034
Dr Pallavi Suresh Ladda, 7207876021, jajupallavi794@gmail.com
Dr Pallavi Suresh jajupallavi794@gmail.com
- Recruiting
Kolhapur Cancer Centre
Kolhāpur, Maharashtra, 416234
Dr Praveen Adusumilli, 9100755777, praveen.adusumilli@kolhapurcancercentre.com
Dr Praveen Adusumilli
- Recruiting
BP Poddar Hospital & Medical Research Ltd
Kolkata, West Bengal, 700053
Dr Prashant Pandey, 9804290687, 2drprashant@gmail.com
Dr Prashant Pandey
- Recruiting
Tata Medical Center
Kolkata, West Bengal, 700160
Dr Jeevan Kumar, MBBS, 9007016755, jeevan.kumar@tmckolkata.com
Dr Jeevan Kumar, MBBS
- Recruiting
Chittaranjan National Cancer Institute
Kolkata, West Bengal, 9830115905
Dr Kalyan Kusum Mukherjee, 9830115905, kkmukherjee4u@hotmail.com
Dr Kalyan Kusum Mukherjee
- Recruiting
K R Hospital
Mysore, Karnataka, 570001
Dr. Mukesh S, +91 9886873788, dal_muk1@hotmail.com
- Recruiting
Kims-Kingsway Hospitals
Nagpur, Maharashtra, 440001
Dr Riya Ballikar, 8334988584, Riaballikar86@gmail.com
Dr Riya Ballikar
- Recruiting
Rhythm Heart And Critical Care
Nagpur, Maharashtra, 440012
Dr Rahuk Darshan Arora, MBBS, 9654438006, drrahularora84@gmail.com
Dr Rahul Darshan Arora, MBBS
- Recruiting
Treat Me Hospital
Nagpur, Maharashtra, 440015
Dr Shriram Kane, MBBS, 9823012851, drshriramkane01@gmail.com
Dr Shriram Kane, MBBS
- Recruiting
Soham Hospital
Nashik, Maharashtra, 422001
Dr Nilesh Wasekar, MBBS, 9766185562, drnilesh123@gmail.com
Dr Nilesh Wasekar, MBBS
- Recruiting
HCG Manavata Cancer Centre
Nashik, Maharashtra, 422002
Dr Raj Nagarkar Vasanthrao, 9823061929, drraj@manavatacancercentre.com
Dr Raj Nagarkar Vasanthrao
- Recruiting
Cancure Day Care Centre
Navi Mumbai, Maharashtra, 400703
Dr Shishir N Shetty, 9820102145, drshishir@hotmil.com
Dr Shishir N Shetty
- Recruiting
The Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)
Navi Mumbai, Maharashtra, 410210
Dr Anbarasan Sekar, 022-68735000, anbarasan157@gmail.com
Dr Anbarasan Sekar
- Recruiting
Max Super Speciality Hospital
New Delhi, New Delhi, 110017
Dr Rayaz Ahmed, 8826033818, rayaz.khalid@maxhealth.com
Dr Rayaz Ahmed
- Recruiting
All India Institute of Medical Sciences
New Delhi, New Delhi, 110029
Dr. Deepam Pushpam, +91 9650629370, deepampushpam@gmail.com
- Recruiting
Jawaharlal Institute of postgraduate medical education and research
Puducherry, Puducherry, 605006
Dr Biswajit Dubashi, 8056338405, drbiswajitdm@gmail.com
Dr Biswajeet Dubasi
- Recruiting
Grant Medical Foundation Ruby Hall Clinic
Pune, Maharashtra, 411001
Dr. Minish Jain, +91 9823133390, minishjain009@gmail.com
- Active, not recruiting
MMFHA Joshi Hospital
Pune, Maharashtra, 411004
- Recruiting
Novo Solitaire Care
Pune, Maharashtra, 411014
Dr Mohite Aniket Balasaheb, MBBS, 9960593303, lifelineaniket@gmail.com
Dr Mohite Aniket Balasaheb, MBBS
- Recruiting
Onco-Life Cancer Centre
Pune, Maharashtra, 530040
Dr Sarang Waghmare, MBBS, 9766915259, drsarangwaghamareolcccr@gmail.com
Dr Sarang Waghmare, MBBS
- Recruiting
Pt.B.D Sharma PGIMS Rohtak
Rohtak, Haryana, 124001
Dr Sudhir Kumar Antri, MBBS, 9315895272, ssmantri74@yahoo.com
Dr Sudhir Kumar Antri, MBBS
- Recruiting
Universal Superspeciality Hospital
Surat, Gujarat, 395001
Dr Amee Patel, MBBS, 9979456297, doctoramipatel@gmail.com
Dr Amme Patel, MBBS
- Recruiting
Unique Hospital Multispeciality and Research Institute
Surat, Gujarat, 395002
Dr. Ankit Patel, +91 9825404202, drankitoncologist@gmail.com
- Recruiting
Kiran Hospital Multi Super Speciality Hospital & Research Centre
Surat, Gujarat, 395004
Dr Priyanka Das, 7405698000, drpriyanka.das@gmail.com
Dr Priyanka Das
- Recruiting
Sunact Cancer Institute Pvt Ltd
Thane, Maharashtra, 400615
Dr Vijay Patil, 9136129135, vijaypatil@sunactcancer.com
Dr Vijay Patil
- Not yet recruiting
HCG City Cancer Centre
Vijayawada, Andhra Pradesh, 520002
Dr Lakshmi Priyadarshini, +91 9966030988, priyadarshini009@gmail.com
- Recruiting
Omega Hospital
Visakhapatnam, Andhra Pradesh, 530040
Dr. Bellala Ravishankar, +91 9849123256, rakesh.neve@gmail.com
About this study
Official title: A Phase 1, Open Label, Dose Escalation, Dose Expansion, Multicenter, First in Human Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of Oral AUR107 in Patients With Relapsed Advanced Malignancies (SHAKTI-1)
An open-label, first-in-human, Phase 1 study in adult patients with relapsed advanced malignancies will be done to assess AUR107 safety, tolerability, pharmacokinetics, pharmacodynamics, and optimal biological dose.
Read the detailed description
This is a Phase I, Open Label, Dose-Escalation, First-in-Human study in adult patients with select relapsed advanced malignancies. The safety and tolerability of oral AUR107 will be evaluated in patients with selected advanced solid tumors (Non-small cell lung cancer, Gastric cancer, Urothelial cancer, Kidney cancer, Colon cancer, and Esophageal cancer) who do not have any available curative or life-prolonging treatment options and have exhausted all effective locally available therapies. The traditional 3+3 design for dose escalation will be used to evaluate the safety, pharmacokinetics/pharmacodynamics, and determine the Optimal Biological Dose of AUR107 as a single agent. The Optimal Biological Dose will be selected using a totality of safety, PK, and PD data.
- Conditions
- Relapsed Malignant Solid Neoplasm
- Being tested
- AUR107
- Keywords
- Relapse malignant neoplasm, Non small cell lung cancer, Gastric cancer, Colon cancer, Esophageal cancer, Kidney cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Stomach Neoplasms, Colonic Neoplasms, Esophageal Neoplasms, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AUR107Drug
Once daily
| Study group | Role | What they receive |
|---|---|---|
| AUR107, 5mg to 200mg | Experimental | Currently, planned dose levels are 5 mg QD, 10 mg QD, 20 mg QD, 40 mg QD, 60 mg QD, 90 mg QD, 135 mg QD, and 200 mg QD Receives: Drug: AUR107 |
What is being measured
The primary outcome is the main question the study is designed to answer.
First cycle Dose Limiting Toxicities (DLT)
Assess dose limiliting toxicities of AUR107
Measured: 28 days
Safety of AUR107 as measured by the number of participants with treatment-related adverse events (AE) graded according to NCI CTCAE version 5.0
The assessment of safety was based on the frequency of deaths, AEs, SAEs, AEs leading to discontinuation of study drug, and abnormalities in specific clinical laboratory assessments. AEs and laboratory values will be graded for severity according to the NCI CTCAE version 5.0.
Measured: 28 days
Optimal Biological Dose
Determine optimal Biological dose
Measured: 28 days
Pharmacokinetics: Maximum concentration (Cmax)
Maximum concentration of AUR107
Measured: Day 1 and Day 15
Pharmacokinetics: Time to Maximum concentration (Tmax)
Tmax in hours
Measured: Day 1 and Day 15
Pharmacokinetics: Area under the curve (AUC)
Area under the curve (AUC) of AUR 107 in h* mcg/mL
Measured: Day 1 and Day 15
Pharmacokinetics: Mean Residence Time (MRT)
Average time the drugs stays in the body
Measured: Day 1 and Day 15
Pharmacokinetics: Terminal elimination half-life
Terminal elimination half-life of AUR 107 in hours
Measured: Day 1 and Day 15
Maximum concentration (Cmax) administered under fasting/fed condition
Compare in fast and fed conditions
Measured: Day 8 and Day 9
Time to Maximum concentration (Tmax) administered under fasting/fed condition
Compare Tmax in fast and fed conditions
Measured: Day 8 and Day 9
Area under curve (AUC) administered under fasting/fed condition
Compare AUC in fast and fed conditions
Measured: Day 8 and Day 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start5 Sep 2023
- Primary completionJan 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed Malignant Solid NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Dose Escalation "3+3" Design
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aurigene Discovery Technologies Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Akhil Kumar, Principal investigator, Aurigene Oncology Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05865002
- Sponsor's protocol ID
- AUR107-101
- Status last verified
- Jan 2026
- First submitted
- 28 Apr 2023
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open Label, Dose Escalation, Dose Expansion, Multicenter, First in Human Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of Oral AUR107 in Patients With Relapsed Advanced Malignancies (SHAKTI-1)
- ClinicalTrials.gov ID
- NCT05865002
- Acronym / sponsor ID
- AUR107-101
- Conditions
- Relapsed Malignant Solid Neoplasm
- Keywords
- Relapse malignant neoplasm, Non small cell lung cancer, Gastric cancer, Colon cancer, Esophageal cancer, Kidney cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Aurigene Discovery Technologies LimitedIndustry (pharma, biotech, devices)
- Study start
- 5 Sep 2023 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 18 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An open-label, first-in-human, Phase 1 study in adult patients with relapsed advanced malignancies will be done to assess AUR107 safety, tolerability, pharmacokinetics, pharmacodynamics, and optimal biological dose.
Detailed description
This is a Phase I, Open Label, Dose-Escalation, First-in-Human study in adult patients with select relapsed advanced malignancies. The safety and tolerability of oral AUR107 will be evaluated in patients with selected advanced solid tumors (Non-small cell lung cancer, Gastric cancer, Urothelial cancer, Kidney cancer, Colon cancer, and Esophageal cancer) who do not have any available curative or life-prolonging treatment options and have exhausted all effective locally available therapies. The traditional 3+3 design for dose escalation will be used to evaluate the safety, pharmacokinetics/pharmacodynamics, and determine the Optimal Biological Dose of AUR107 as a single agent. The Optimal Biological Dose will be selected using a totality of safety, PK, and PD data.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Dose Escalation "3+3" Design
| Arm | Type | Receives |
|---|---|---|
| AUR107, 5mg to 200mg | Experimental | Drug: AUR107Currently, planned dose levels are 5 mg QD, 10 mg QD, 20 mg QD, 40 mg QD, 60 mg QD, 90 mg QD, 135 mg QD, and 200 mg QD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Males and females ≥ 18 years of age.
- Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1.
- Acceptable bone marrow and organ function at screening as described below:
- Ability to swallow and retain oral medications.
- Histopathological diagnosis of a solid tumor. Note: The solid tumors must be in Stage IV at screening.
Key exclusion criteria (22 listed)
- Systemic anti-cancer therapy, such as chemotherapy, biological therapy, or immunomodulatory drug therapy, received within the past 28 days or 5 half-lives, whichever is longer, from Cycle 1 Day 1 of the study.
- Note: Concomitant use of low-dose prednisone (up to 10 mg/day) or medroxyprogesterone is allowed.
- Note: Patients with CRPC (castrate-resistant prostate cancer) should continue to receive ongoing medical castration with LHRH analogs, and such patients are allowed.
- Presence of acute or chronic toxicity resulting from prior anticancer treatment, with the exception of alopecia or nail changes, that has not resolved to Grade ≤ 1, as determined by NCI CTCAE v 5.0.
- Definitive Radiotherapy within the last 21 days of Cycle 1 Day 1 (limited field palliative radiation is allowed and no restrictions during the screening period or during the trial)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AUR107Once daily | Drug | AUR107, 5mg to 200mg |
Primary outcome
First cycle Dose Limiting Toxicities (DLT)
Time frame: 28 days
Assess dose limiliting toxicities of AUR107
Safety of AUR107 as measured by the number of participants with treatment-related adverse events (AE) graded according to NCI CTCAE version 5.0
Time frame: 28 days
The assessment of safety was based on the frequency of deaths, AEs, SAEs, AEs leading to discontinuation of study drug, and abnormalities in specific clinical laboratory assessments. AEs and laboratory values will be graded for severity according to the NCI CTCAE version 5.0.
Optimal Biological Dose
Time frame: 28 days
Determine optimal Biological dose
Pharmacokinetics: Maximum concentration (Cmax)
Time frame: Day 1 and Day 15
Maximum concentration of AUR107
Pharmacokinetics: Time to Maximum concentration (Tmax)
Time frame: Day 1 and Day 15
Tmax in hours
Pharmacokinetics: Area under the curve (AUC)
Time frame: Day 1 and Day 15
Area under the curve (AUC) of AUR 107 in h* mcg/mL
Pharmacokinetics: Mean Residence Time (MRT)
Time frame: Day 1 and Day 15
Average time the drugs stays in the body
Pharmacokinetics: Terminal elimination half-life
Time frame: Day 1 and Day 15
Terminal elimination half-life of AUR 107 in hours
Maximum concentration (Cmax) administered under fasting/fed condition
Time frame: Day 8 and Day 9
Compare in fast and fed conditions
Time to Maximum concentration (Tmax) administered under fasting/fed condition
Time frame: Day 8 and Day 9
Compare Tmax in fast and fed conditions
Area under curve (AUC) administered under fasting/fed condition
Time frame: Day 8 and Day 9
Compare AUC in fast and fed conditions
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Akhil Kumar principal investigator
Aurigene Oncology Limited
37 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AUR107 in people with Relapsed Malignant Solid Neoplasm, run by Aurigene Discovery Technologies Limited at 37 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Suchit Kumbhare (+91 8104730078, suchit_k@aurigene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First cycle Dose Limiting Toxicities (DLT) (time frame: 28 days). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.